FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
168145–168168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1979
LUTEINIZING HORMONE (LH) RIA
K792000 · CEP
Cis Radiopharmaceuticals, Inc.
Chemistry · 25d
Cleared Oct 30, 1979
VOLU-SOL STAT STAIN
K792017 · IAF
Volu Sol Medical Industries
Hematology · 21d
Cleared Oct 30, 1979
ESKACHEM, CK-MB REAGENT
K792023 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 21d
Cleared Oct 30, 1979
LIPOTROL
K792024 · JJY
Helena Laboratories
Chemistry · 21d
Cleared Oct 30, 1979
LYOPHILIZED HDL CHOLESTEROL CONTROLS
K792025 · JJY
Helena Laboratories
Chemistry · 21d
Cleared Oct 30, 1979
PREGTELL I
K792027 · JHJ
Central Biological Co.
Immunology · 21d
Cleared Oct 30, 1979
TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT
K792030 · BZO
Airlife, Inc.
Anesthesiology · 21d
Cleared Oct 30, 1979
CORTISOL RADIOIMMUNOASSAY SYSTEM
K792036 · CGR
Radioimmunoassay, Inc.
Chemistry · 19d
Cleared Oct 30, 1979
WILLIAM HARVEY H-1500 BLOOD OXYGENATOR
K792039 · DTZ
C.R. Bard, Inc.
Cardiovascular · 18d
Cleared Oct 30, 1979
DHEA-SULFATE TEST SET
K792041 · JKC
Wien Laboratories, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
PAP-CHECK RIA KIT
K792043 · JFH
Serono Laboratories, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
BIOVATION NEPHELOMETER
K792045 · JQX
Biovation, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
URIC ACID STANDARD
K792046 · JIS
Gilford Diagnostics
Chemistry · 18d
Cleared Oct 30, 1979
CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,
K792047 · BZO
Airlife, Inc.
Anesthesiology · 18d
Cleared Oct 30, 1979
DELTA ROLLING SELF-LICKING WALKER
K792064 · ITJ
Staricat, Inc.
Physical Medicine · 15d
Cleared Oct 30, 1979
TRACHEOSTOMY CARE KIT
K792069 · BTO
National Patent Development Corp.
Anesthesiology · 15d
Cleared Oct 30, 1979
C-ERA-100 COMPUTERIZED ELECTRIC RESPON
K792085 · GWJ
Micro-Shev , Ltd.
Neurology · 13d
Cleared Oct 26, 1979
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
K791373 · CFE
Hoffmann-La Roche, Inc.
Chemistry · 94d
Cleared Oct 26, 1979
VITAL CATHETER
K791489 · FIE
Hospal Medical Corp.
Gastroenterology & Urology · 84d
Cleared Oct 26, 1979
UNIPUNCTURE CATHETER
K791490 · FIE
Hospal Medical Corp.
Gastroenterology & Urology · 84d
Cleared Oct 26, 1979
FLOW MEDICAL X-RAY PROTECTIVE GLOVES
K791522 · KPY
Flow X-Ray Corp.
Radiology · 77d
Cleared Oct 26, 1979
HOLLISTER KARAYA PASTE
K791525 · EXB
Hollister, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 26, 1979
HOLLISTER STOMA POUCH SKIN BARRIER
K791526 · EXB
Hollister, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 26, 1979
HOLLISTER STOMA POUCH WITH MICRO ADHES
K791535 · EXB
Hollister, Inc.
Gastroenterology & Urology · 77d